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Clinical Trial Results:
A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma (DREAMM 4)

Summary
EudraCT number	2018-002816-29
Trial protocol	DE ES
Global end of trial date

Results information
Results version number	v1
This version publication date	01 Nov 2022
First version publication date	01 Nov 2022
Other versions	v2 , v3 , v4 , v5

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

205207

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS

Public contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Interim

Date of interim/final analysis

18 Oct 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

18 Oct 2021

Global end of trial reached?

Main objective of the trial

To determine the recommended Phase 2 dose (RP2D) of belantamab mafodotin in combination with pembrolizumab, and to evaluate safety and clinical activity of the combination in subjects with RRMM.

Protection of trial subjects

Not Applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

14 Mar 2019

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

36 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 12

Country: Number of subjects enrolled

Germany: 8

Country: Number of subjects enrolled

Spain: 4

Country: Number of subjects enrolled

United States: 17

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study consists of Part 1 and Part 2. Total 41 participants were enrolled. Out of 41 participants, 13 participants were randomized in Part 1 (Dose Escalation) and 28 were randomized to Part 2 (Cohort Expansion). The primary analysis results are presented. Additional results will be provided within one year after study completion.

Screening details

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Arm description

Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin+Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Belantamab mafodotin was administered as a 2.5 mg/kg dose in combination with 200 mg of pembrolizumab via IV infusion

Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg

Arm description

Participants were administered 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin+Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Belantamab mafodotin was administered as a 3.4 mg/kg dose in combination with 200 mg of pembrolizumab via IV infusion

Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Arm description

Belantamab mafodotin recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with fixed dose of 200 mg of pembrolizumab determined in the Dose Escalation phase was administered to participants via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

Arm type

Experimental

Investigational medicinal product name

Belantamab mafodotin+Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Belantamab mafodotin was administered as a 2.5 mg/kg dose in combination with 200 mg of pembrolizumab via IV infusion

Number of subjects in period 1	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Started	6	7	28
Completed	3	3	5
Not completed	3	4	23
Consent withdrawn by subject	3	2	6
Physician decision	-	-	1
On Study Treatment	-	-	4
Lost to follow-up	-	1	-
In Follow-up	-	1	12

Baseline characteristics

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Reporting group title

Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Reporting group description

Reporting group title

Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg

Reporting group description

Reporting group title

Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Reporting group description

Reporting group values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Total
Number of subjects	6	7	28	41
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	2	1	17	20
From 65-84 years	4	6	11	21
85 years and over	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	66.8 ± 12.09	67.7 ± 9.21	61.5 ± 9.41	-
Sex: Female, Male
Units: Participants
Female	5	4	10	19
Male	1	3	18	22
Race/Ethnicity, Customized
Units: Subjects
ASIAN	0	0	1	1
BLACK OR AFRICAN AMERICAN	1	2	4	7
WHITE	5	5	23	33

End points

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Reporting group title

Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Reporting group description

Reporting group title

Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg

Reporting group description

Reporting group title

Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Reporting group description

Primary: Part 1 - Number of participants with adverse events (AEs) and serious adverse events (SAEs)

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End point title

Part 1 - Number of participants with adverse events (AEs) and serious adverse events (SAEs) ^[1] ^[2]

End point description

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.

End point type

Primary

End point timeframe

Up to approximately 31 months

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
AEs	6	7
SAEs	4	5

No statistical analyses for this end point

Primary: Part 1 - Number of participants with dose limiting toxicities (DLTs)

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End point title

Part 1 - Number of participants with dose limiting toxicities (DLTs) ^[3] ^[4]

End point description

DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: any Grade 4 and 3 non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value, hematologic toxicity lasting >=7 days, except Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia associated with clinically significant bleeding. Grade 3 or greater febrile neutropenia lasting >48 hours (h) despite adequate treatment, Nephrotoxicity requiring dialysis, Liver toxicity, prolonged delay (>14 days) in initiating Cycle 2 due to any treatment related toxicity, any treatment-related toxicity that causes discontinuation of treatment during Cycle 1, any other toxicity considered to be dose-limiting that occurs beyond 21 days and any other event which in the judgment of the investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT.

End point type

Primary

End point timeframe

Up to 21 days

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants	0	0

No statistical analyses for this end point

Primary: Part 1 - Number of participants with worst-case grade change from baseline in hematology parameters

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End point title

Part 1 - Number of participants with worst-case grade change from baseline in hematology parameters ^[5] ^[6]

End point description

Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cells (WBC) count, lymphocytes, neutrophils and platelet count. The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 31 months

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
Hemoglobin Decreased (Anemia), Any Grade Increase	4	2
Hemoglobin Decreased (Anemia), Increase to Grade 3	3	1
Hemoglobin Decreased (Anemia), Increase to Grade 4	0	0
Hemoglobin Increased, Any Grade Increase	0	0
Hemoglobin Increased, Increase to Grade 3	0	0
Hemoglobin Increased, Increase to Grade 4	0	0
WBC Increased (Leukocytosis), Any Grade Increase	0	0
WBC Increased (Leukocytosis), Increase to Grade 3	0	0
WBC Increased (Leukocytosis), Increase to Grade 4	0	0
WBC Decreased, Any Grade Increase	3	3
WBC Decreased, Increase to Grade 3	1	1
WBC Decreased, Increase to Grade 4	0	0
Lymphocyte Decreased, Any Grade Increase	4	1
Lymphocyte Decreased, Increase to Grade 3	1	1
Lymphocyte Decreased, Increase to Grade 4	1	0
Lymphocyte Increased, Any Grade Increase	0	1
Lymphocyte Increased, Increase to Grade 3	0	0
Lymphocyte Increased, Increase to Grade 4	0	0
Neutrophil Decreased, Any Grade Increase	5	2
Neutrophil Decreased, Increase to Grade 3	2	1
Neutrophil Decreased, Increase to Grade 4	0	1
Platelet Decreased, Any Grade Increase	5	5
Platelet Decreased, Increase to Grade 3	3	3
Platelet Decreased, Increase to Grade 4	1	0

No statistical analyses for this end point

Primary: Part 1 - Number of participants with worst-case change post-baseline in hematology parameters

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End point title

Part 1 - Number of participants with worst-case change post-baseline in hematology parameters ^[7] ^[8]

End point description

Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 31 months

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
Basophils, Decrease to Low	0	0
Basophils, Change to Normal or No Change	6	6
Basophils, Increase to High	0	0
Eosinophils, Decrease to Low	2	1
Eosinophils, Change to Normal or No Change	4	6
Eosinophils, Increase to High	0	0
MCHC, Decrease to Low	0	1
MCHC, Change to Normal or No Change	6	4
MCHC, Increase to High	0	2
MCH, Decrease to Low	2	0
MCH, Change to Normal or No Change	3	5
MCH, Increase to High	0	1
MCV, Decrease to Low	1	0
MCV, Change to Normal or No Change	5	6
MCV, Increase to High	0	1
Erythrocytes, Decrease to Low	0	1
Erythrocytes, Change to Normal or No Change	6	6
Erythrocytes, Increase to High	0	0
Hematocrit, Decrease to Low	0	0
Hematocrit, Change to Normal or No Change	5	7
Hematocrit, Increase to High	1	0
Monocytes, Decrease to Low	0	0
Monocytes, Change to Normal or No Change	3	4
Monocytes, Increase to High	3	3
Neutrophils, Decrease to Low	0	0
Neutrophils, Change to Normal or No Change	0	0
Neutrophils, Increase to High	0	0
Reticulocyte, Decrease to Low	4	0
Reticulocyte, Change to Normal or No Change	0	4
Reticulocyte, Increase to High	4	2

No statistical analyses for this end point

Primary: Part 1 - Number of participants with worst-case grade change from baseline in lab chemistry parameters

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End point title

Part 1 - Number of participants with worst-case grade change from baseline in lab chemistry parameters ^[9] ^[10]

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase, magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 31 months

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
Glucose Increased, Any Grade Increase	0	0
Glucose Increased, Increase to Grade 3	0	0
Glucose Increased, Increase to Grade 4	0	0
Glucose Decreased, Any Grade Increase	1	0
Glucose Decreased, Increase to Grade 3	0	0
Glucose Decreased, Increase to Grade 4	0	0
ALT Increased, Any Grade Increase	3	0
ALT Increased, Increase to Grade 3	0	0
ALT Increased, Increase to Grade 4	0	0
Albumin Decreased, Any Grade Increase	1	4
Albumin Decreased, Increase to Grade 3	0	0
Albumin Decreased, Increase to Grade 4	0	0
ALP Increased, Any Grade Increase	3	2
ALP Increased, Increase to Grade 3	0	0
ALP Increased, Increase to Grade 4	0	0
AST Increased, Any Grade Increase	5	5
AST Increased, Increase to Grade 3	0	0
AST Increased, Increase to Grade 4	0	0
Blood bilirubin Increased, Any Grade Increase	0	1
Blood bilirubin Increased, Increase to Grade 3	0	0
Blood bilirubin Increased, Increase to Grade 4	0	0
Calcium Increased, Any Grade Increase	2	1
Calcium Increased, Increase to Grade 3	0	0
Calcium Increased, Increase to Grade 4	0	0
Calcium Decreased, Any Grade Increase	2	0
Calcium Decreased, Increase to Grade 3	0	0
Calcium Decreased, Increase to Grade 4	0	0
CPK Increased, Any Grade Increase	1	2
CPK Increased, Increase to Grade 3	0	0
CPK Increased, Increase to Grade 4	0	0
Creatinine Increased, Any Grade Increase	2	1
Creatinine Increased, Increase to Grade 3	0	0
Creatinine Increased, Increase to Grade 4	0	0
GGT Increased, Any Grade Increase	3	2
GGT Increased, Increase to Grade 3	0	0
GGT Increased, Increase to Grade 4	0	0
Magnesium Increased, Any Grade Increase	0	0
Magnesium Increased, Increase to Grade 3	0	0
Magnesium Increased, Increase to Grade 4	0	0
Magnesium Decreased, Any Grade Increase	2	2
Magnesium Decreased, Increase to Grade 3	0	0
Magnesium Decreased, Increase to Grade 4	0	0
Phosphate Decreased, Any Grade Increase	2	0
Phosphate Decreased, Increase to Grade 3	0	0
Phosphate Decreased, Increase to Grade 4	0	0
Potassium Increased, Any Grade Increase	0	0
Potassium Increased, Increase to Grade 3	0	0
Potassium Increased, Increase to Grade 4	0	0
Potassium Decreased, Any Grade Increase	2	2
Potassium Decreased, Increase to Grade 3	0	1
Potassium Decreased, Increase to Grade 4	0	0
Sodium Increased, Any Grade Increase	0	0
Sodium Increased, Increase to Grade 3	0	0
Sodium Increased, Increase to Grade 4	0	0
Sodium Decreased, Any Grade Increase	1	3
Sodium Decreased, Increase to Grade 3	0	2
Sodium Decreased, Increase to Grade 4	0	0

No statistical analyses for this end point

Primary: Part 1 - Number of participants with worst-case change post-baseline in lab chemistry parameters

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End point title

Part 1 - Number of participants with worst-case change post-baseline in lab chemistry parameters ^[11] ^[12]

End point description

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3) and troponin. The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 31 months

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
Calcium, Decrease to Low	1	2
Calcium, Change to Normal or No Change	4	4
Calcium, Increase to High	1	1
Carbon dioxide, Decrease to Low	2	1
Carbon dioxide, Change to Normal or No Change	3	4
Carbon dioxide, Increase to High	1	1
Chloride, Decrease to Low	1	2
Chloride, Change to Normal or No Change	4	4
Chloride, Increase to High	1	1
Direct bilirubin, Decrease to Low	0	0
Direct bilirubin, Change to Normal or No Change	4	5
Direct bilirubin, Increase to High	1	1
Protein, Decrease to Low	2	3
Protein, Change to Normal or No Change	3	4
Protein, Increase to High	1	1
TSH, Decrease to Low	0	0
TSH, Change to Normal or No Change	3	4
TSH, Increase to High	3	2
T4, Decrease to Low	1	0
T4, Change to Normal or No Change	5	6
T4, Increase to High	1	0
T3, Decrease to Low	1	1
T3, Change to Normal or No Change	1	0
T3, Increase to High	0	0

No statistical analyses for this end point

Primary: Part 1 - Number of participants with abnormal urinalysis results

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End point title

Part 1 - Number of participants with abnormal urinalysis results ^[13] ^[14]

End point description

Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 31 months

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
Glucose, No Change/Decreased	6	5
Glucose, Any Increase	0	1
Ketones, No Change/Decreased	3	5
Ketones, Any Increase	3	1
Occult Blood, No Change/Decreased	4	4
Occult Blood, Any Increase	2	1
Protein, No Change/Decreased	4	4
Protein, Any Increase	2	2

No statistical analyses for this end point

Primary: Part 1 - Changes from baseline in urine potential of hydrogen (pH) at indicated time points

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End point title

Part 1 - Changes from baseline in urine potential of hydrogen (pH) at indicated time points ^[15] ^[16]

End point description

Urine samples were collected from participants to assess urine pH levels. 99999= Mean and standard deviation is not applicable as only a single participant was analyzed.

End point type

Primary

End point timeframe

Baseline (Day 1) and Week 46

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	2	1
Units: Potential of Hydrogen (pH)
arithmetic mean (standard deviation)	1.0 ± 2.83	0.0 ± 99999

No statistical analyses for this end point

Primary: Part 1 - Changes from baseline in urine specific gravity at indicated time points

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End point title

Part 1 - Changes from baseline in urine specific gravity at indicated time points ^[17] ^[18]

End point description

Urine samples were collected from participants to assess urine specific gravity. 99999= Mean and standard deviation is not applicable as only a single participant was analyzed.

End point type

Primary

End point timeframe

Baseline (Day 1) and Week 46

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	2	1
Units: Ratio
arithmetic mean (standard deviation)	-0.0010 ± 0.00566	0.0100 ± 99999

No statistical analyses for this end point

Primary: Part 1 - Number of participants with worst-case grade change from baseline in vital signs: diastolic blood pressure (DBP) and systolic blood pressure (SBP)

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End point title

Part 1 - Number of participants with worst-case grade change from baseline in vital signs: diastolic blood pressure (DBP) and systolic blood pressure (SBP) ^[19] ^[20]

End point description

DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.

End point type

Primary

End point timeframe

Baseline (Day 1) and up to approximately 31 months

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
DBP, Any Grade Increase	6	4
DBP, Increase to Grade 2	2	1
DBP, Increase to Grade 3	0	0
SBP, Any Grade Increase	6	5
SBP, Increase to Grade 2	3	2
SBP, Increase to Grade 3	0	3

No statistical analyses for this end point

Primary: Part 1 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature

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End point title

Part 1 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature ^[21] ^[22]

End point description

Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Primary

End point timeframe

Baseline and up to approximately 31 months

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants
Pulse Rate\|Baseline To Low	3	2
Temperature\|Baseline To Low	0	1
Pulse Rate\|Baseline To Normal or No Change	3	3
Temperature\|Baseline To Normal or No Change	4	6
Pulse Rate\|Baseline To High	0	2
Temperature\|Baseline To High	2	0

No statistical analyses for this end point

Primary: Part 2 - Percentage of participants with overall response rate (ORR)

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End point title

Part 2 - Percentage of participants with overall response rate (ORR) ^[23] ^[24]

End point description

ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.

End point type

Primary

End point timeframe

Up to approximately 31 months

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Percentage of Participants
number (confidence interval 95%)	43 (24.5 to 62.8)

No statistical analyses for this end point

Secondary: Part 1 - Percentage of participants with ORR

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End point title

Part 1 - Percentage of participants with ORR ^[25]

End point description

ORR was defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR), according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h.

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Percentage of Participants
number (confidence interval 95%)	67 (22.3 to 95.7)	43 (9.9 to 81.6)

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with AEs and SAEs

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End point title

Part 2 - Number of participants with AEs and SAEs ^[26]

End point description

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
AEs	27
SAEs	5

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in hematology parameters

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End point title

Part 2 - Number of participants with worst-case grade change from baseline in hematology parameters ^[27]

End point description

Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cell (WBC) count, lymphocytes, neutrophils and platelet. The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
Hemoglobin Decreased (Anemia), Any Grade Increase	10
Hemoglobin Decreased (Anemia), Increase to Grade 3	3
Hemoglobin Decreased (Anemia), Increase to Grade 4	0
Hemoglobin Increased, Any Grade Increase	2
Hemoglobin Increased, Increase to Grade 3	0
Hemoglobin Increased, Increase to Grade 4	0
WBC Increased (Leukocytosis), Any Grade Increase	1
WBC Increased (Leukocytosis), Increase to Grade 3	0
WBC Increased (Leukocytosis), Increase to Grade 4	0
WBC Decreased, Any Grade Increase	11
WBC Decreased, Increase to Grade 3	1
WBC Decreased, Increase to Grade 4	2
Lymphocyte Decreased, Any Grade Increase	13
Lymphocyte Decreased, Increase to Grade 3	3
Lymphocyte Decreased, Increase to Grade 4	3
Lymphocyte Increased, Any Grade Increase	2
Lymphocyte Increased, Increase to Grade 3	1
Lymphocyte Increased, Increase to Grade 4	0
Neutrophil Decreased, Any Grade Increase	9
Neutrophil Decreased, Increase to Grade 3	1
Neutrophil Decreased, Increase to Grade 4	1
Platelet Decreased, Any Grade Increase	18
Platelet Decreased, Increase to Grade 3	7
Platelet Decreased, Increase to Grade 4	4

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case change post-baseline in hematology parameters

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End point title

Part 2 - Number of participants with worst-case change post-baseline in hematology parameters ^[28]

End point description

Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), Erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
Basophils, Decrease to Low	0
Basophils, Change to Normal or No Change	22
Basophils, Increase to High	1
Eosinophils, Decrease to Low	2
Eosinophils, Change to Normal or No Change	22
Eosinophils, Increase to High	3
MCHC, Decrease to Low	3
MCHC, Change to Normal or No Change	24
MCHC, Increase to High	0
MCH, Decrease to Low	3
MCH, Change to Normal or No Change	16
MCH, Increase to High	3
MCV, Decrease to Low	0
MCV, Change to Normal or No Change	25
MCV, Increase to High	2
Erythrocytes, Decrease to Low	0
Erythrocytes, Change to Normal or No Change	25
Erythrocytes, Increase to High	2
Hematocrit, Decrease to Low	3
Hematocrit, Change to Normal or No Change	23
Hematocrit, Increase to High	1
Monocytes, Decrease to Low	0
Monocytes, Change to Normal or No Change	20
Monocytes, Increase to High	7
Neutrophils, Decrease to Low	0
Neutrophils, Change to Normal or No Change	1
Neutrophils, Increase to High	0
Reticulocyte, Decrease to Low	2
Reticulocyte, Change to Normal or No Change	14
Reticulocyte, Increase to High	5

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in lab chemistry parameters

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End point title

Part 2 - Number of participants with worst-case grade change from baseline in lab chemistry parameters ^[29]

End point description

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase, magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
Glucose Increased, Any Grade Increase	1
Glucose Increased, Increase to Grade 3	0
Glucose Increased, Increase to Grade 4	0
Glucose Decreased, Any Grade Increase	4
Glucose Decreased, Increase to Grade 3	0
Glucose Decreased, Increase to Grade 4	0
ALT Increased, Any Grade Increase	5
ALT Increased, Increase to Grade 3	1
ALT Increased, Increase to Grade 4	0
Albumin Decreased, Any Grade Increase	9
Albumin Decreased, Increase to Grade 3	1
Albumin Decreased, Increase to Grade 4	0
ALP Increased, Any Grade Increase	8
ALP Increased, Increase to Grade 3	1
ALP Increased, Increase to Grade 4	0
AST Increased, Any Grade Increase	20
AST Increased, Increase to Grade 3	1
AST Increased, Increase to Grade 4	0
Blood bilirubin Increased, Any Grade Increase	3
Blood bilirubin Increased, Increase to Grade 3	1
Blood bilirubin Increased, Increase to Grade 4	0
Calcium Increased, Any Grade Increase	3
Calcium Increased, Increase to Grade 3	0
Calcium Increased, Increase to Grade 4	0
Calcium Decreased, Any Grade Increase	3
Calcium Decreased, Increase to Grade 3	0
Calcium Decreased, Increase to Grade 4	0
CPK Increased, Any Grade Increase	4
CPK Increased, Increase to Grade 3	1
CPK Increased, Increase to Grade 4	0
Creatinine Increased, Any Grade Increase	8
Creatinine Increased, Increase to Grade 3	0
Creatinine Increased, Increase to Grade 4	1
GGT Increased, Any Grade Increase	10
GGT Increased, Increase to Grade 3	1
GGT Increased, Increase to Grade 4	0
Magnesium Increased, Any Grade Increase	1
Magnesium Increased, Increase to Grade 3	1
Magnesium Increased, Increase to Grade 4	0
Magnesium Decreased, Any Grade Increase	6
Magnesium Decreased, Increase to Grade 3	0
Magnesium Decreased, Increase to Grade 4	0
Phosphate Decreased, Any Grade Increase	3
Phosphate Decreased, Increase to Grade 3	1
Phosphate Decreased, Increase to Grade 4	0
Potassium Increased, Any Grade Increase	0
Potassium Increased, Increase to Grade 3	0
Potassium Increased, Increase to Grade 4	0
Potassium Decreased, Any Grade Increase	4
Potassium Decreased, Increase to Grade 3	1
Potassium Decreased, Increase to Grade 4	0
Sodium Increased, Any Grade Increase	0
Sodium Increased, Increase to Grade 3	0
Sodium Increased, Increase to Grade 4	0
Sodium Decreased, Any Grade Increase	4
Sodium Decreased, Increase to Grade 3	1
Sodium Decreased, Increase to Grade 4	1

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case change post-baseline in lab chemistry parameters

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End point title

Part 2 - Number of participants with worst-case change post-baseline in lab chemistry parameters ^[30]

End point description

Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3) and troponin. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes from baseline, and increases to high values have been presented.

End point type

Secondary

End point timeframe

Baseline and up to 31 months

Notes
[30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
Calcium, Decrease to Low	4
Calcium, Change to Normal or No Change	18
Calcium, Increase to High	5
Carbon dioxide, Decrease to Low	4
Carbon dioxide, Change to Normal or No Change	15
Carbon dioxide, Increase to High	9
Chloride, Decrease to Low	5
Chloride, Change to Normal or No Change	19
Chloride, Increase to High	3
Direct bilirubin, Decrease to Low	2
Direct bilirubin, Change to Normal or No Change	15
Direct bilirubin, Increase to High	7
Protein, Decrease to Low	6
Protein, Change to Normal or No Change	19
Protein, Increase to High	2
TSH, Decrease to Low	1
TSH, Change to Normal or No Change	17
TSH, Increase to High	8
T4, Decrease to Low	2
T4, Change to Normal or No Change	24
T4, Increase to High	0
T3, Decrease to Low	0
T3, Change to Normal or No Change	0
T3, Increase to High	0

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with abnormal urinalysis results

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End point title

Part 2 - Number of participants with abnormal urinalysis results ^[31]

End point description

Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.

End point type

Secondary

End point timeframe

Baseline and Up to approximately 31 months

Notes
[31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
Glucose, No Change/Decreased	25
Glucose, Any Increase	1
Ketones, No Change/Decreased	21
Ketones, Any Increase	5
Occult Blood, No Change/Decreased	16
Occult Blood, Any Increase	8
Protein, No Change/Decreased	20
Protein, Any Increase	6

No statistical analyses for this end point

Secondary: Part 2 - Changes from baseline in urine specific gravity at indicated time points

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End point title

Part 2 - Changes from baseline in urine specific gravity at indicated time points ^[32]

End point description

Urine samples were collected from participants to assess urine specific gravity.

End point type

Secondary

End point timeframe

Baseline and Week 70

Notes
[32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	3
Units: Ratio
arithmetic mean (standard deviation)	0.0017 ± 0.00289

No statistical analyses for this end point

Secondary: Part 2 - Changes from baseline in urine pH at indicated time points

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End point title

Part 2 - Changes from baseline in urine pH at indicated time points ^[33]

End point description

Urine samples were collected from participants to assess urine pH levels.

End point type

Secondary

End point timeframe

Baseline and Week 70

Notes
[33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	4
Units: Potential of Hydrogen (pH)
arithmetic mean (standard deviation)	0.63 ± 0.946

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in vital signs: DBP and SBP

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End point title

Part 2 - Number of participants with worst-case grade change from baseline in vital signs: DBP and SBP ^[34]

End point description

DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (<=120 millimeter of mercury [mmHg]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP: Grade 0 (<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
DBP, Any Grade Increase	20
DBP, Increase to Grade 2	12
DBP, Increase to Grade 3	2
SBP, Any Grade Increase	24
SBP, Increase to Grade 2	16
SBP, Increase to Grade 3	6

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature

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End point title

Part 2 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature ^[35]

End point description

Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low <60 beats per minute [bpm] and high >100 bpm); For body temperature (<=35 degrees Celsius or >=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
Pulse Rate\|Baseline To Low	10
Temperature\|Baseline To Low	2
Pulse Rate\|Baseline to Normal or No Change	12
Temperature\|Baseline to Normal or No Change	23
Pulse Rate\|Baseline to High	6
Temperature\|Baseline to High	3

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with maximum worst-case change from baseline in best corrected visual acuity test (BCVA) scores

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End point title

Part 2 - Number of participants with maximum worst-case change from baseline in best corrected visual acuity test (BCVA) scores ^[36]

End point description

BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any maximum worst-case change from baseline categories are presented for right and left eyes. No change/improved vision is defined as a change from baseline <0.12; a possible worsened vision is defined as a change from baseline >=0.12 to <0.3; a definite worsened vision is defined as a change from baseline >=0.3 logMAR score. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	27
Units: Participants
Right Eye\|No change/improved vision	16
Left Eye\|No change/improved vision	14
Right Eye\|Possible worsened vision	4
Left Eye\|Possible worsened vision	5
Right Eye\|Definite worsened vision	7
Left Eye\|Definite worsened vision	8

No statistical analyses for this end point

Secondary: Part 2 - Time taken for the onset of first occurrence of worsening in BCVA score

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End point title

Part 2 - Time taken for the onset of first occurrence of worsening in BCVA score ^[37]

End point description

The time for the onset of any visual acuity event (change from baseline logMAR score >= 0.3 in either eye) was calculated.

End point type

Secondary

End point timeframe

Up to 31 months

Notes
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	10
Units: Days
median (full range (min-max))	78 (37 to 273)

No statistical analyses for this end point

Secondary: Part 2 - Outcome of first occurrence of worsening eye in BCVA score

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End point title

Part 2 - Outcome of first occurrence of worsening eye in BCVA score ^[38]

End point description

The onset of any visual acuity event (change from baseline in logMAR score >= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and unresolved outcome of the worsening eye were presented.

End point type

Secondary

End point timeframe

Up to 31 months

Notes
[38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	10
Units: Participants
Resolved prior to end of treatment exposure	7
Resolved post end of treatment exposure	2
Not Resolved	1

No statistical analyses for this end point

Secondary: Part 2 - Duration of first occurrence of worsening in BCVA score

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End point title

Part 2 - Duration of first occurrence of worsening in BCVA score ^[39]

End point description

The time from onset of any visual acuity event (change from baseline logMAR score >= 0.3 in either eye) until the event is resolved (change from baseline logMAR score < 0.3 in both eyes) was used to calculate the duration of first occurrence.

End point type

Secondary

End point timeframe

Up to 31 months

Notes
[39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	9
Units: Days
median (full range (min-max))	47 (3 to 65)

No statistical analyses for this end point

Secondary: Part 2 - Number of events of participants with definite worsen vision of worsening in BCVA score

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End point title

Part 2 - Number of events of participants with definite worsen vision of worsening in BCVA score ^[40]

End point description

A definite worsened vision was defined as a change from baseline >=0.3 logMAR score.

End point type

Secondary

End point timeframe

Up to 31 months

Notes
[40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	10
Units: Events
One occurrence	6
Two occurrences	2
Three OR more occurrences	2

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with outcome post treatment exposure of worsening in BCVA score

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End point title

Part 2 - Number of participants with outcome post treatment exposure of worsening in BCVA score ^[41]

End point description

The event was considered resolved if the change from baseline in logMAR score < 0.3 in both eyes.

End point type

Secondary

End point timeframe

Up to 31 months

Notes
[41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	3
Units: Participants
Resolved	2
Not resolved, follow-up ongoing	0
Not resolved, follow-up ended	1

No statistical analyses for this end point

Secondary: Part 2 - Duration of resolution post-treatment exposure of worsening in BCVA score

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End point title

Part 2 - Duration of resolution post-treatment exposure of worsening in BCVA score ^[42]

End point description

The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score >= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score < 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date.

End point type

Secondary

End point timeframe

Up to 31 months

Notes
[42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	2
Units: Days
median (full range (min-max))	34.5 (22 to 47)

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with post-baseline decline in BCVA to light perception or no light perception

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End point title

Part 2 - Number of participants with post-baseline decline in BCVA to light perception or no light perception ^[43]

End point description

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[44]
Units: Participants

Notes
[44] - Data was not collected

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case shift from baseline in ophthalmological epithelium exam

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End point title

Part 2 - Number of participants with worst-case shift from baseline in ophthalmological epithelium exam ^[45]

End point description

Participants with worst-case shift from baseline in corneal epithelium defects by right eye, left eye and worse eye are presented as normal (N), abnormal (AN) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
Right Eye\|Baseline N, Post-Baseline N	3
Left Eye\|Baseline N, Post-Baseline N	2
Worst eye\|Baseline N, Post-Baseline N	3
Right Eye\|Baseline N, Post-Baseline AN	16
Left Eye\|Baseline N, Post-Baseline AN	16
Worst eye\|Baseline N, Post-Baseline AN	17
Right Eye\|Baseline AN, Post-Baseline N	0
Left Eye\|Baseline AN, Post-Baseline N	1
Worst eye\|Baseline AN, Post-Baseline N	0
Right Eye\|Baseline AN, Post-Baseline AN	8
Left Eye\|Baseline AN, Post-Baseline AN	8
Worst eye\|Baseline AN, Post-Baseline AN	7
Right Eye\|Baseline N, Post-Baseline Missing	0
Left Eye\|Baseline N, Post-Baseline Missing	1
Worst eye\|Baseline N, Post-Baseline Missing	1
Right Eye\|Baseline AN, Post-Baseline Missing	1
Left Eye\|Baseline AN, Post-Baseline Missing	0
Worst eye\|Baseline AN, Post-Baseline Missing	0

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case shift from baseline in corneal examinations

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End point title

Part 2 - Number of participants with worst-case shift from baseline in corneal examinations ^[46]

End point description

Participants with worst-case shift from baseline in corneal examination: corneal ulcer(CU), epithelial microcystic edema(EME), subepithelial haze(SH), corneal neovascularization(CN) and microcysts without edema(MWE), by right eye (R), left eye (L) and worse eye (W) are presented as yes (Y), no (N) and missing (M). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
CU indicator L\|Baseline N, Post-Baseline N	23
CU indicator R\|Baseline N, Post-Baseline N	21
CU indicator W\|Baseline N, Post-Baseline N	23
EME indicator L eye\|Baseline N, Post-Baseline N	17
EME indicator R\|Baseline N, Post-Baseline N	16
EME indicator W\|Baseline N, Post-Baseline N	17
MWE indicator L\|Baseline N, Post-Baseline N	8
MWE indicator R\|Baseline N, Post-Baseline N	7
MWE indicator W\|Baseline N, Post-Baseline N	8
CN indicator L\|Baseline N, Post-Baseline N	22
CN indicator R\|Baseline N, Post-Baseline N	20
CN indicator W\|Baseline N, Post-Baseline N	21
SH indicator L\|Baseline N, Post-Baseline N	17
SH indicator R\|Baseline N, Post-Baseline N	18
SH indicator W\|Baseline N, Post-Baseline N	18
CU indicator L\|Baseline N, Post-Baseline Y	0
CU indicator R\|Baseline N, Post-Baseline Y	0
CU indicator W\|Baseline N, Post-Baseline Y	0
EME indicator L\|Baseline N, Post-Baseline Y	6
EME indicator R\|Baseline N, Post-Baseline Y	5
EME indicator W\|Baseline N, Post-Baseline Y	6
MWE indicator L\|Baseline N, Post-Baseline Y	15
MWE indicator R\|Baseline N, Post-Baseline Y	14
MWE indicator W\|Baseline N, Post-Baseline Y	15
CN indicator L\|Baseline N, Post-Baseline Y	1
CN indicator R\|Baseline N, Post-Baseline Y	1
CN indicator W\|Baseline N, Post-Baseline Y	1
SH indicator L\|Baseline N, Post-Baseline Y	8
SH indicator R\|Baseline N, Post-Baseline Y	6
SH indicator W\|Baseline N, Post-Baseline Y	8
CU indicator L\|Baseline N, Post-Baseline Missing	1
CU indicator R\|Baseline N, Post-Baseline M	1
CU indicator W\|Baseline N, Post-Baseline M	1
EME indicator L\|Baseline N, Post-Baseline M	1
EME indicator R\|Baseline N, Post-Baseline M	1
EME indicator W\|Baseline N, Post-Baseline M	1
MWE indicator L\|Baseline N, Post-Baseline M	1
MWE indicator R eye\|Baseline N, Post-Baseline M	1
MWE indicator W\|Baseline N, Post-Baseline M	1
CN indicator L\|Baseline N, Post-Baseline M	2
CN indicator R\|Baseline N, Post-Baseline M	2
CN indicator W\|Baseline N, Post-Baseline M	2
SH indicator L\|Baseline N, Post-Baseline M	1
SH indicator R\|Baseline N, Post-Baseline M	1
SH indicator W\|Baseline N, Post-Baseline M	1
CU indicator L\|Baseline Y, Post-Baseline N	0
CU indicator R\|Baseline Y, Post-Baseline N	0
CU indicator W\|Baseline Y, Post-Baseline N	0
EME indicator L\|Baseline Y, Post-Baseline N	0
EME indicator R\|Baseline Y, Post-Baseline N	0
EME indicator W\|Baseline Y, Post-Baseline N	0
MWE indicator L\|Baseline Y, Post-Baseline N	0
MWE indicator R\|Baseline Y, Post-Baseline N	0
MWE indicator W\|Baseline Y, Post-Baseline N	0
CN indicator L\|Baseline Y, Post-Baseline N	0
CN indicator R\|Baseline Y, Post-Baseline N	0
CN indicator W\|Baseline Y, Post-Baseline N	0
SH indicator L\|Baseline Y, Post-Baseline N	1
SH indicator R\|Baseline Y, Post-Baseline N	1
SH indicator W\|Baseline Y, Post-Baseline N	0
CU indicator L\|Baseline Y, Post-Baseline Y	0
CU indicator R\|Baseline Y, Post-Baseline Y	0
CU indicator W\|Baseline Y, Post-Baseline Y	0
EME indicator L\|Baseline Y, Post-Baseline Y	0
EME indicator R\|Baseline Y, Post-Baseline Y	0
EME indicator W\|Baseline Y, Post-Baseline Y	0
MWE indicator L\|Baseline Y, Post-Baseline Y	0
MWE indicator R\|Baseline Y, Post-Baseline Y	0
MWE indicator W\|Baseline Y, Post-Baseline Y	0
CN indicator L\|Baseline Y, Post-Baseline Y	0
CN indicator R\|Baseline Y, Post-Baseline Y	1
CN indicator W\|Baseline Y, Post-Baseline Y	1
SH indicator L\|Baseline Y, Post-Baseline Y	0
SH indicator R\|Baseline Y, Post-Baseline Y	0
SH indicator W\|Baseline Y, Post-Baseline Y	0
CU indicator L\|Baseline Y, Post-Baseline Missing	0
CU indicator R\|Baseline Y, Post-Baseline Missing	0
CU indicator W\|Baseline Y, Post-Baseline Missing	0
EME indicator L\|Baseline Y, Post-Baseline Missing	0
EME indicator R\|Baseline Y, Post-Baseline Missing	0
EME indicator W\|Baseline Y, Post-Baseline Missing	0
MWE indicator L\|Baseline Y, Post-Baseline Missing	0
MWE indicator R\|Baseline Y, Post-Baseline Missing	0
MWE indicator W\|Baseline Y, Post-Baseline Missing	0
CN indicator L\|Baseline Y, Post-Baseline Missing	0
CN indicator R\|Baseline Y, Post-Baseline Missing	0
CN indicator W\|Baseline Y, Post-Baseline Missing	0
SH indicator L\|Baseline Y, Post-Baseline Missing	0
SH indicator R\|Baseline Y, Post-Baseline Missing	0
SH indicator W\|Baseline Y, Post-Baseline Missing	0
CU indicator L\|Baseline Missing, Post-Baseline N	3
CU indicator R\|Baseline Missing, Post-Baseline N	5
CU indicator W\|Baseline Missing, Post-Baseline N	3
EME indicator L\|Baseline Missing, Post-Baseline N	2
EME indicator R\|Baseline Missing, Post-Baseline N	3
EME indicator W\|Baseline Missing, Post-Baseline N	2
MWE indicator L\|Baseline Missing, Post-Baseline N	0
MWE indicator R\|Baseline Missing, Post-Baseline N	1
MWE indicator W\|Baseline Missing, Post-Baseline N	0
CN indicator L\|Baseline Missing, Post-Baseline N	3
CN indicator R\|Baseline Missing, Post-Baseline N	3
CN indicator W\|Baseline Missing, Post-Baseline N	2
SH indicator L\|Baseline Missing, Post-Baseline N	1
SH indicator R\|Baseline Missing, Post-Baseline N	2
SH indicator W\|Baseline Missing, Post-Baseline N	1
CU indicator L\|Baseline Missing, Post-Baseline Y	0
CU indicator R\|Baseline Missing, Post-Baseline Y	0
CU indicator W\|Baseline Missing, Post-Baseline Y	0
EME indicator L\|Baseline Missing, Post-Baseline Y	1
EME indicator R\|Baseline Missing, Post-Baseline Y	2
EME indicator W\|Baseline Missing, Post-Baseline Y	1
MWE indicator L\|Baseline Missing, Post-Baseline Y	3
MWE indicator R\|Baseline Missing, Post-Baseline Y	4
MWE indicator W\|Baseline Missing, Post-Baseline Y	3
CN indicator L\|Baseline Missing, Post-Baseline Y	0
CN indicator R\|Baseline Missing, Post-Baseline Y	1
CN indicator W\|Baseline Missing, Post-Baseline Y	1
SH indicator L\|Baseline Missing, Post-Baseline Y	0
SH indicator R\|Baseline Missing, Post-Baseline Y	0
SH indicator W\|Baseline Missing, Post-Baseline Y	0
CU indicator L\|Baseline Missing, Post-Baseline M	1
CU indicator R\|Baseline Missing, Post-Baseline M	1
CU indicator W\|Baseline Missing, Post-Baseline M	1
EME indicator L\|Baseline Missing, Post-Baseline M	1
EME indicator R\|Baseline Missing, Post-Baseline M	1
EME indicator W\|Baseline Missing, Post-Baseline M	1
MWE indicator L\|Baseline Missing, Post-Baseline M	1
MWE indicator R\|Baseline Missing, Post-Baseline M	1
MWE indicator W\|Baseline Missing, Post-Baseline M	1
CN indicator L\|Baseline Missing, Post-Baseline M	0
CN indicator R\|Baseline Missing, Post-Baseline M	0
CN indicator W\|Baseline Missing, Post-Baseline M	0
SH indicator L\|Baseline Missing, Post-Baseline M	0
SH indicator R\|Baseline Missing, Post-Baseline M	0
SH indicator W\|Baseline Missing, Post-Baseline M	0

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worse case post-baseline punctate keratopathy findings

Top of page

End point title

Part 2 - Number of participants with worse case post-baseline punctate keratopathy findings ^[47]

End point description

Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	26
Units: Participants
Right eye, Worst findings\|None	2
Left eye, Worst findings\|None	2
Worst eye, Worst findings\|None	2
Right eye, Most frequent findings\|None	10
Left eye, Most frequent findings\|None	8
Worst eye, Most frequent findings\|None	7
Right eye, Worst findings\|Mild	11
Left eye, Worst findings\|Mild	9
Worst eye, Worst findings\|Mild	8
Right eye, Most frequent findings\|Mild	14
Left eye, Most frequent findings\|Mild	13
Worst eye, Most frequent findings\|Mild	14
Right eye, Worst findings\|Moderate	7
Left eye, Worst findings\|Moderate	9
Worst eye, Worst findings\|Moderate	10
Right eye, Most frequent findings\|Moderate	2
Left eye, Most frequent findings\|Moderate	5
Worst eye, Most frequent findings\|Moderate	5
Right eye, Worst findings\|Severe	6
Left eye, Worst findings\|Severe	6
Worst eye, Worst findings\|Severe	6
Right eye, Most frequent findings\|Severe	0
Left eye, Most frequent findings\|Severe	0
Worst eye, Most frequent findings\|Severe	0

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with worst-case shift from baseline in lens examinations

Top of page

End point title

Part 2 - Number of participants with worst-case shift from baseline in lens examinations ^[48]

End point description

Participants with worst-case shift from baseline in corneal examination which included: clear(C), pseudophakia(P), nuclear sclerosis(NS), cortical cataract(CC) and posterior subcapsular cataract(PSC) by right eye(R), left eye(L) and worse eye(W) are presented as yes (Y), no (N) and missing(M). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Participants
C indicator L\|Baseline N, Post-Baseline N	12
C indicator R\|Baseline N, Post-Baseline N	12
C indicator W\|Baseline N, Post-Baseline N	12
CC indicator L\|Baseline N, Post-Baseline N	7
CC indicator R\|Baseline N, Post-Baseline N	7
CC indicator W\|Baseline N, Post-Baseline N	7
NS indicator L\|Baseline N, Post-Baseline N	2
NSI indicator R\|Baseline N, Post-Baseline N	2
NS indicator W\|Baseline N, Post-Baseline N	2
PSC indicator L\|Baseline N, Post-Baseline N	7
PSC indicator R\|Baseline N, Post-Baseline N	7
PSC indicator W\|Baseline N, Post-Baseline N	6
P indicator L\|Baseline N, Post-Baseline N	12
P indicator R\|Baseline N, Post-Baseline N	12
P indicator W\|Baseline N, Post-Baseline N	12
C indicator L\|Baseline N, Post-Baseline Y	0
C indicator R\|Baseline N, Post-Baseline Y	0
C indicator W\|Baseline N, Post-Baseline Y	0
CC indicator L\|Baseline N, Post-Baseline Y	3
CC indicator R\|Baseline N, Post-Baseline Y	3
CC indicator W\|Baseline N, Post-Baseline Y	3
NS indicator L\|Baseline N, Post-Baseline Y	1
NS indicator R\|Baseline N, Post-Baseline Y	1
NS indicator W\|Baseline N, Post-Baseline Y	1
PSC indicator L\|Baseline N, Post-Baseline Y	3
PSC indicator R\|Baseline N, Post-Baseline Y	1
PSC indicator W\|Baseline N, Post-Baseline Y	3
P indicator L\|Baseline N, Post-Baseline Y	2
P indicator R\|Baseline N, Post-Baseline Y	2
P indicator W\|Baseline N, Post-Baseline Y	3
C indicator L\|Baseline N, Post-Baseline Missing	3
C indicator R\|Baseline N, Post-Baseline Missing	3
C indicator W\|Baseline N, Post-Baseline Missing	3
CC indicator L\|Baseline N, Post-Baseline Missing	2
CC indicator R\|Baseline N, Post-Baseline Missing	1
CC indicator W\|Baseline N, Post-Baseline Missing	2
NS indicator L\|Baseline N, Post-Baseline Missing	0
NS indicator R\|Baseline N, Post-Baseline Missing	0
NS indicator W\|Baseline N, Post-Baseline Missing	0
PSC indicator L\|Baseline N, Post-Baseline Missing	0
PSC indicator R\|Baseline N, Post-Baseline Missing	0
PSC indicator W\|Baseline N, Post-Baseline Missing	0
P indicator L\|Baseline N, Post-Baseline Missing	3
P indicator R\|Baseline N, Post-Baseline Missing	3
P indicator W\|Baseline N, Post-Baseline Missing	3
C indicator L\|Baseline Y, Post-Baseline N	3
C indicator R\|Baseline Y, Post-Baseline N	3
C indicator W\|Baseline Y, Post-Baseline N	3
CC indicator L\|Baseline Y, Post-Baseline N	0
CC indicator R\|Baseline Y, Post-Baseline N	0
CC indicator WBaseline Y, Post-Baseline N	0
NS indicator L\|Baseline Y, Post-Baseline N	1
NS indicator R\|Baseline Y, Post-Baseline N	1
NS indicator W\|Baseline Y, Post-Baseline N	1
PSC indicator L\|Baseline Y, Post-Baseline N	0
PSC indicator R\|Baseline Y, Post-Baseline N	0
PSC indicator W\|Baseline Y, Post-Baseline N	0
P indicator L\|Baseline Y, Post-Baseline N	1
P indicator R\|Baseline Y, Post-Baseline N	1
P indicator W\|Baseline Y, Post-Baseline N	0
C indicator L\|Baseline Y, Post-Baseline Y	10
C indicator R\|Baseline Y, Post-Baseline Y	10
C indicator W\|Baseline Y, Post-Baseline Y	10
CC indicator L\|Baseline Y, Post-Baseline Y	2
CC indicator R\|Baseline Y, Post-Baseline Y	2
CC indicator W\|Baseline Y, Post-Baseline Y	2
NS indicator L\|Baseline Y, Post-Baseline Y	8
NS indicator R\|Baseline Y, Post-Baseline Y	8
NS indicator W\|Baseline Y, Post-Baseline Y	8
PSC indicator L\|Baseline Y, Post-Baseline Y	2
PSC indicator R\|Baseline Y, Post-Baseline Y	4
PSC indicator W\|Baseline Y, Post-Baseline Y	4
P indicator L\|Baseline Y, Post-Baseline Y	10
P indicator R\|Baseline Y, Post-Baseline Y	10
P indicator W\|Baseline Y, Post-Baseline Y	10
C indicator L\|Baseline Y, Post-Baseline Missing	0
C indicator R\|Baseline Y, Post-Baseline Missing	0
C indicator W\|Baseline Y, Post-Baseline Missing	0
CC indicator L\|Baseline Y, Post-Baseline Missing	1
CC indicator R\|Baseline Y, Post-Baseline Missing	2
CC indicator W\|Baseline Y, Post-Baseline Missing	1
NS indicator L\|Baseline Y, Post-Baseline Missing	3
NS indicator R\|Baseline Y, Post-Baseline Missing	3
NS indicator W\|Baseline Y, Post-Baseline Missing	3
PSC indicator L\|Baseline Y, Post-Baseline Missing	3
PSC indicator R\|Baseline Y, Post-Baseline Missing	3
PSC indicator W\|Baseline Y, Post-Baseline Missing	3
P indicator L\|Baseline Y, Post-Baseline Missing	0
P indicator R\|Baseline Y, Post-Baseline Missing	0
P indicator W\|Baseline Y, Post-Baseline Missing	0
C indicator L\|Baseline Missing, Post-Baseline N	0
C indicator R\|Baseline Missing, Post-Baseline N	0
C indicator W\|Baseline Missing, Post-Baseline N	0
CC indicator LBaseline Missing, Post-Baseline N	2
CC indicator R\|Baseline Missing, Post-Baseline N	3
CC indicator W\|Baseline Missing, Post-Baseline N	2
NS indicator LBaseline Missing, Post-Baseline N	2
NS indicator RBaseline Missing, Post-Baseline N	2
NS indicator WBaseline Missing, Post-Baseline N	2
PSC indicator L\|Baseline Missing, Post-Baseline N	1
PSC indicator R\|Baseline Missing, Post-Baseline N	1
PSC indicator W\|Baseline Missing, Post-Baseline N	1
P indicator L\|Baseline Missing, Post-Baseline N	0
P indicator R\|Baseline Missing, Post-Baseline N	0
P indicator W\|Baseline Missing, Post-Baseline N	0
C indicator L\|Baseline Missing, Post-Baseline Y	0
C indicator R\|Baseline Missing, Post-Baseline Y	0
C indicator W\|Baseline Missing, Post-Baseline Y	0
CC indicator L\|Baseline Missing, Post-Baseline Y	1
CC indicator R\|Baseline Missing, Post-Baseline Y	0
CC indicator W\|Baseline Missing, Post-Baseline Y	1
NS indicator L\|Baseline Missing, Post-Baseline Y	1
NS indicator R\|Baseline Missing, Post-Baseline Y	1
NS indicator W\|Baseline Missing, Post-Baseline Y	1
PSC indicator L\|Baseline Missing, Post-Baseline Y	2
PSC indicator R\|Baseline Missing, Post-Baseline Y	2
PSC indicator W\|Baseline Missing, Post-Baseline Y	1
P indicator L\|Baseline Missing, Post-Baseline Y	0
P indicator R\|Baseline Missing, Post-Baseline Y	0
P indicator W\|Baseline Missing, Post-Baseline Y	0
C indicator L\|Baseline Missing, Post-Baseline M	0
C indicator R\|Baseline Missing, Post-Baseline M	0
C indicator W\|Baseline Missing, Post-Baseline M	0
CC indicator L\|Baseline Missing, Post-Baseline M	10
CC indicator R\|Baseline Missing, Post-Baseline M	10
CC indicator W\|Baseline Missing, Post-Baseline M	10
NS indicator L\|Baseline Missing, Post-Baseline M	10
NS indicator R\|Baseline Missing, Post-Baseline M	10
NS indicator W\|Baseline Missing, Post-Baseline M	10
PSC indicator L\|Baseline Missing, Post-Baseline M	10
PSC indicator R\|Baseline Missing, Post-Baseline M	10
PSC indicator W\|Baseline Missing, Post-Baseline M	10
P indicator L\|Baseline Missing, Post-Baseline M	0
P indicator R\|Baseline Missing, Post-Baseline M	0
P indicator W\|Baseline Missing, Post-Baseline M	0

No statistical analyses for this end point

Secondary: Part 2 - Percentage of participants with clinical benefit rate

Top of page

End point title

Part 2 - Percentage of participants with clinical benefit rate ^[49]

End point description

Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Percentage of Participants
number (confidence interval 95%)	43 (24.5 to 62.8)

No statistical analyses for this end point

Secondary: Part 2 - Duration of response

Top of page

End point title

Part 2 - Duration of response ^[50]

End point description

Duration of response was defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. 99999= Upper limit of 95% CI was not estimate due to limited number of events.

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	12
Units: Months
median (confidence interval 95%)	7.6 (1.4 to 99999)

No statistical analyses for this end point

Secondary: Part 2 - Time to response

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End point title

Part 2 - Time to response ^[51]

End point description

Time to response (TTR) was defined as the time between the date of first dose and the first documented evidence of response (PR or better) among participants who achieved a confirmed response of PR or better.

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	12
Units: Months
median (confidence interval 95%)	0.7 (0.7 to 1.4)

No statistical analyses for this end point

Secondary: Part 2 - Time to best response

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End point title

Part 2 - Time to best response ^[52]

End point description

Time to best response was defined as the time between the date of first dose and the first best documented response (PR or better) among participants who achieved a confirmed response of PR or better.

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	12
Units: Months
median (full range (min-max))	1.7 (0.7 to 5.6)

No statistical analyses for this end point

Secondary: Part 2 - Progression-free survival

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End point title

Part 2 - Progression-free survival ^[53]

End point description

Progression-free survival was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Months
median (confidence interval 95%)	2.5 (0.8 to 5.6)

No statistical analyses for this end point

Secondary: Part 2 - Time to disease progression

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End point title

Part 2 - Time to disease progression ^[54]

End point description

Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Months
median (confidence interval 95%)	2.5 (0.8 to 5.6)

No statistical analyses for this end point

Secondary: Part 2 - Overall survival

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End point title

Part 2 - Overall survival ^[55]

End point description

Overall Survival was defined as the time from first dose until death due to any cause. 99999= Median and upper limit of 95% CI was not estimate due to limited number of events.

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Months
median (confidence interval 95%)	99999 (19.1 to 99999)

No statistical analyses for this end point

Secondary: Part 1 - Maximum concentration (Cmax) for belantamab mafodotin after first dose

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End point title

Part 1 - Maximum concentration (Cmax) for belantamab mafodotin after first dose ^[56]

End point description

Blood samples were collected for Pharmacokinetic (PK) analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[57]	0 ^[58]
Units: Microgram/millilitre (ug/mL)
geometric mean (geometric coefficient of variation)	±	±

Notes
[57] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.
[58] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 2 - Cmax for belantamab mafodotin after first dose

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End point title

Part 2 - Cmax for belantamab mafodotin after first dose ^[59]

End point description

End point type

Secondary

End point timeframe

Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[60]
Units: ug/mL
geometric mean (geometric coefficient of variation)	±

Notes
[60] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 1 - End of infusion concentration (C-EOI) for belantamab mafodotin

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End point title

Part 1 - End of infusion concentration (C-EOI) for belantamab mafodotin ^[61]

End point description

End point type

Secondary

End point timeframe

EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11

Notes
[61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[62]	0 ^[63]
Units: ug/mL
geometric mean (geometric coefficient of variation)	±	±

Notes
[62] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.
[63] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 2 - C-EOI for belantamab mafodotin

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End point title

Part 2 - C-EOI for belantamab mafodotin ^[64]

End point description

End point type

Secondary

End point timeframe

EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle from Cycle 1 till Cycle 11

Notes
[64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[65]
Units: ug/mL
geometric mean (geometric coefficient of variation)	±

Notes
[65] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 1 - Time of Cmax (Tmax) for belantamab mafodotin after first dose

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End point title

Part 1 - Time of Cmax (Tmax) for belantamab mafodotin after first dose ^[66]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[67]	0 ^[68]
Units: Hour
geometric mean (geometric coefficient of variation)	±	±

Notes
[67] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.
[68] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 2 - Tmax for belantamab mafodotin after first dose

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End point title

Part 2 - Tmax for belantamab mafodotin after first dose ^[69]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[70]
Units: Hour
geometric mean (geometric coefficient of variation)	±

Notes
[70] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 1 - Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin

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End point title

Part 1 - Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ^[71]

End point description

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

Notes
[71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[72]	0 ^[73]
Units: ug/mL
median (full range (min-max))	( to )	( to )

Notes
[72] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.
[73] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 2 - Ctrough for belantamab mafodotin

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End point title

Part 2 - Ctrough for belantamab mafodotin ^[74]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

Notes
[74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[75]
Units: ug/mL
median (full range (min-max))	( to )

Notes
[75] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 1 - Last time point where the concentration is above the limit of quantification (Tlast) for belantamab mafodotin after first dose

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End point title

Part 1 - Last time point where the concentration is above the limit of quantification (Tlast) for belantamab mafodotin after first dose ^[76]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[77]	0 ^[78]
Units: Hour
geometric mean (geometric coefficient of variation)	±	±

Notes
[77] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.
[78] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 2 - Tlast for belantamab mafodotin after first dose

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End point title

Part 2 - Tlast for belantamab mafodotin after first dose ^[79]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[80]
Units: Hour
geometric mean (geometric coefficient of variation)	±

Notes
[80] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 1 - Area under plasma concentration-time curve (AUC) from time 0 to end of the dosing interval [AUC (0-tau)] for belantamab mafodotin after first dose

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End point title

Part 1 - Area under plasma concentration-time curve (AUC) from time 0 to end of the dosing interval [AUC (0-tau)] for belantamab mafodotin after first dose ^[81]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[82]	0 ^[83]
Units: Hourmicrogram/millilitre (hug/mL)
geometric mean (geometric coefficient of variation)	±	±

Notes
[82] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.
[83] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 2 - AUC (0-tau) for belantamab mafodotin after first dose

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End point title

Part 2 - AUC (0-tau) for belantamab mafodotin after first dose ^[84]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[85]
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	±

Notes
[85] - Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin.

No statistical analyses for this end point

Secondary: Part 1 - Cmax for total monoclonal antibody (mAb) after first dose

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End point title

Part 1 - Cmax for total monoclonal antibody (mAb) after first dose ^[86]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	4	7
Units: ug/mL
geometric mean (geometric coefficient of variation)	43.57 ± 7.1	64.45 ± 21.5

No statistical analyses for this end point

Secondary: Part 2 - Cmax for total mAb after first dose

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End point title

Part 2 - Cmax for total mAb after first dose ^[87]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	26
Units: ug/mL
geometric mean (geometric coefficient of variation)	46.7 ± 23.3

No statistical analyses for this end point

Secondary: Part 1 - C-EOI for total mAb

Top of page

End point title

Part 1 - C-EOI for total mAb ^[88]

End point description

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. 99999= Median and full range were not estimate due to limited number PK samples.

End point type

Secondary

End point timeframe

EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle from Cycle 1 till Cycle 11

Notes
[88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: ug/mL
median (full range (min-max))
Cycle 1 Day 1 (n=4, 7)	40.15 (36.3 to 44.4)	65.3 (44.6 to 73.5)
Cycle 2 Day 1 (n=4, 4)	53.9 (39.1 to 66.3)	64.65 (1.61 to 90.1)
Cycle 5 Day 1 (n=4, 3)	54.65 (46.5 to 78.2)	73.9 (42.6 to 101)
Cycle 8 Day 1 (n=1, 2)	63.70 (63.70 to 63.70)	39.75 (12.9 to 66.6)
Cycle 11 Day 1 (n=1, 1)	65.40 (65.40 to 65.40)	54.80 (54.80 to 54.80)

No statistical analyses for this end point

Secondary: Part 2 - C-EOI for total mAb

Top of page

End point title

Part 2 - C-EOI for total mAb ^[89]

End point description

Blood samples were collected for PK analysis of belantamab when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle from Cycle 1 till Cycle 5

Notes
[89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: ug/mL
median (full range (min-max))
Cycle 1 Day 1 (n = 21)	48.6 (17.4 to 68.9)
Cycle 2 Day 1 (n = 23)	53.0 (26.5 to 71.1)
Cycle 5 Day 1 (n = 6)	52.35 (36.9 to 70.5)

No statistical analyses for this end point

Secondary: Part 1 - Tmax for total mAb after first dose

Top of page

End point title

Part 1 - Tmax for total mAb after first dose ^[90]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	4	7
Units: Hour
median (full range (min-max))	1.100 (0.53 to 2.18)	1.520 (0.75 to 2.05)

No statistical analyses for this end point

Secondary: Part 2 - Tmax for total mAb after first dose

Top of page

End point title

Part 2 - Tmax for total mAb after first dose ^[91]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[91] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	26
Units: Hour
median (full range (min-max))	0.945 (0.47 to 2.33)

No statistical analyses for this end point

Secondary: Part 1 - Ctrough for total mAb

Top of page

End point title

Part 1 - Ctrough for total mAb ^[92]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

Notes
[92] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: ug/mL
median (full range (min-max))
Cycle 1 Day 1 (n= 3, 4)	5.42 (3.85 to 7.87)	13.35 (1.83 to 13.5)
Cycle 4 Day 1 (n=5, 2)	99999 (99999 to 99999)	18.8 (18.1 to 19.5)
Cycle 7 Day 1 (n=1, 2)	26.9 (26.9 to 26.9)	45.05 (23.9 to 66.2)
Cycle 10 Day 1 (n= 1, 1)	18.4 (18.4 to 18.4)	21.7 (21.7 to 21.7)
Cycle 13 Day 1 (n=2, 0)	18.05 (18.0 to 18.1)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Part 2 - Ctrough for total mAb

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End point title

Part 2 - Ctrough for total mAb ^[93]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 4

Notes
[93] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: ug/mL
median (full range (min-max))
Cycle 1 Day 1 (n = 20)	7.74 (1.28 to 12.70)
Cycle 4 Day 1 (n= 7)	11.60 (9.15 to 31.0)

No statistical analyses for this end point

Secondary: Part 1 - Last time point where the concentration is above the limit of quantification (Tlast) for total mAb after first dose

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End point title

Part 1 - Last time point where the concentration is above the limit of quantification (Tlast) for total mAb after first dose ^[94]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	5	7
Units: Hour
median (full range (min-max))	501.800 (70.03 to 507.23)	481.580 (72.27 to 551.80)

No statistical analyses for this end point

Secondary: Part 2 - Tlast for total mAb after first dose

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End point title

Part 2 - Tlast for total mAb after first dose ^[95]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Hour
median (full range (min-max))	503.140 (72.50 to 2060.68)

No statistical analyses for this end point

Secondary: Part 1 - AUC (0-tau) for total mAb after first dose

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End point title

Part 1 - AUC (0-tau) for total mAb after first dose ^[96]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	3	4
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	6237.2 ± 17.9	10817.8 ± 48.5

No statistical analyses for this end point

Secondary: Part 2 - AUC (0-tau) for total mAb after first dose

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End point title

Part 2 - AUC (0-tau) for total mAb after first dose ^[97]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	19
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	7949 ± 27.2

No statistical analyses for this end point

Secondary: Part 1 - Cmax for cysteine maleimidocaproyl monomethyl auristatin F (Cys-mcMMAF) after first dose

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End point title

Part 1 - Cmax for cysteine maleimidocaproyl monomethyl auristatin F (Cys-mcMMAF) after first dose ^[98]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	2	5
Units: Nanogram/millilitre (ng/mL)
geometric mean (geometric coefficient of variation)	1.5799 ± 30.4	1.0966 ± 40.9

No statistical analyses for this end point

Secondary: Part 2 - Cmax for cys-mcMMAF after first dose

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End point title

Part 2 - Cmax for cys-mcMMAF after first dose ^[99]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[99] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	26
Units: ng/mL
geometric mean (geometric coefficient of variation)	1.2481 ± 111.5

No statistical analyses for this end point

Secondary: Part 1 - C-EOI for cys-mcMMAF after first dose

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End point title

Part 1 - C-EOI for cys-mcMMAF after first dose ^[100]

End point description

End point type

Secondary

End point timeframe

EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle from Cycle 1 till Cycle 11

Notes
[100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: ng/mL
median (full range (min-max))
Cycle 1 Day 1 (n=2, 7)	0.711 (0.342 to 1.08)	0.763 (0.169 to 1.98)
Cycle 2 Day 1 (n=3, 6)	0.431 (0.148 to 0.517)	99999 (99999 to 99999)
Cycle 5 Day 1 (n=5, 3)	0.345 (0.205 to 0.878)	2.09 (0.736 to 3.13)
Cycle 8 Day 1 (n=2, 2)	0.442 (0.31 to 0.573)	2.331 (0.082 to 4.58)
Cycle 11 Day 1 (n=1, 1)	0.347 (0.347 to 0.347)	0.685 (0.685 to 0.685)

No statistical analyses for this end point

Secondary: Part 2 - C-EOI for cys-mcMMAF after first dose

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End point title

Part 2 - C-EOI for cys-mcMMAF after first dose ^[101]

End point description

Blood samples were collected for PK analysis of belantamab when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. 99999= Median and full range were not estimate due to limited number PK samples.

End point type

Secondary

End point timeframe

EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle from Cycle 1 till Cycle 11

Notes
[101] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: ng/mL
median (full range (min-max))
Cycle 1 Day 1 (n = 27)	99999 (99999 to 99999)
Cycle 2 Day 1 (n = 23)	0.342 (0.145 to 0.87)
Cycle 5 Day 1 (n = 9)	0.389 (0.202 to 0.772)
Cycle 8 Day 1 (n = 6)	99999 (99999 to 99999)
Cycle 11 Day 1 (n = 4)	0.359 (0.151 to 0.738)

No statistical analyses for this end point

Secondary: Part 1 - Tmax for cys-mcMMAF after first dose

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End point title

Part 1 - Tmax for cys-mcMMAF after first dose ^[102]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[102] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	2	5
Units: Hour
median (full range (min-max))	13.510 (4.05 to 22.97)	4.120 (0.57 to 73.03)

No statistical analyses for this end point

Secondary: Part 2 - Tmax for cys-mcMMAF after first dose

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End point title

Part 2 - Tmax for cys-mcMMAF after first dose ^[103]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[103] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	26
Units: Hour
median (full range (min-max))	23.580 (0.52 to 70.65)

No statistical analyses for this end point

Secondary: Part 1 - Tlast for cys-mcMMAF after first dose

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End point title

Part 1 - Tlast for cys-mcMMAF after first dose ^[104]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[104] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	3	7
Units: Hour
median (full range (min-max))	161.380 (70.03 to 168.13)	171.250 (72.27 to 501.28)

No statistical analyses for this end point

Secondary: Part 2 - Tlast for cys-mcMMAF after first dose

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End point title

Part 2 - Tlast for cys-mcMMAF after first dose ^[105]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[105] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: Hour
median (full range (min-max))	167.510 (23.90 to 503.15)

No statistical analyses for this end point

Secondary: Part 1 - Ctrough for cys-mcMMAF

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End point title

Part 1 - Ctrough for cys-mcMMAF ^[106]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 19

Notes
[106] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: ng/mL
median (full range (min-max))
Cycle 1 Day 1 (n= 3, 6)	99999 (99999 to 99999)	99999 (99999 to 99999)
Cycle 4 Day 1 (n=5, 3)	99999 (99999 to 99999)	99999 (99999 to 99999)
Cycle 7 Day 1 (n=2, 2)	99999 (99999 to 99999)	0.72 (0.109 to 1.33)
Cycle 10 Day 1 (n=1, 1)	99999 (99999 to 99999)	99999 (99999 to 99999)
Cycle 13 Day 1 (n=2, 0)	99999 (99999 to 99999)	99999 (99999 to 99999)
Cycle 16 Day 1 (n=2, 0)	99999 (99999 to 99999)	99999 (99999 to 99999)
Cycle 19 Day 1 (n=1, 0)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Part 2 - Ctrough for cys-mcMMAF

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End point title

Part 2 - Ctrough for cys-mcMMAF ^[107]

End point description

End point type

Secondary

End point timeframe

Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13

Notes
[107] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	28
Units: ng/mL
median (full range (min-max))
Cycle 1 Day 1 (n=23)	99999 (99999 to 99999)
Cycle 4 Day 1 (n=10)	99999 (99999 to 99999)
Cycle 7 Day 1 (n= 6)	99999 (99999 to 99999)
Cycle 10 Day 1 (n= 4)	99999 (99999 to 99999)
Cycle 13 Day 1 (n=1)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Part 1 - AUC from time 0 to 168 h after dosing [AUC (0-168h)] for Cys-mcMMAF after first dose

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End point title

Part 1 - AUC from time 0 to 168 h after dosing [AUC (0-168h)] for Cys-mcMMAF after first dose ^[108]

End point description

Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. 99999= Geometric coefficient of variation is not applicable as only a single participant was analyzed.

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[108] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	1	4
Units: Hournanogram/milliliter (hng/mL)
geometric mean (geometric coefficient of variation)	155.27 ± 99999	90.61 ± 34.5

No statistical analyses for this end point

Secondary: Part 2 - AUC (0-168 h) for cys-mcMMAF after first dose

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End point title

Part 2 - AUC (0-168 h) for cys-mcMMAF after first dose ^[109]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[109] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	18
Units: h*ng/mL
geometric mean (geometric coefficient of variation)	128.38 ± 70.9

No statistical analyses for this end point

Secondary: Part 1 - Cmax for pembrolizumab after first dose

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End point title

Part 1 - Cmax for pembrolizumab after first dose ^[110]

End point description

Blood samples were collected for PK analysis of pembrolizumab when administered intravenously in combination with belantamab mafodotin. PK parameter was determined using standard non-compartmental methods.

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[111]	0 ^[112]
Units: ug/mL
geometric mean (geometric coefficient of variation)	±	±

Notes
[111] - PK data were not collected and analyzed for pembrolizumab.
[112] - PK data were not collected and analyzed for pembrolizumab.

No statistical analyses for this end point

Secondary: Part 2 - Cmax for pembrolizumab after first dose

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End point title

Part 2 - Cmax for pembrolizumab after first dose ^[113]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[113] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[114]
Units: ug/mL
geometric mean (geometric coefficient of variation)	±

Notes
[114] - PK data were not collected and analyzed for pembrolizumab.

No statistical analyses for this end point

Secondary: Part 1 - Tmax for pembrolizumab after first dose

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End point title

Part 1 - Tmax for pembrolizumab after first dose ^[115]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[115] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[116]	0 ^[117]
Units: Hour
geometric mean (geometric coefficient of variation)	±	±

Notes
[116] - PK data were not collected and analyzed for pembrolizumab.
[117] - PK data were not collected and analyzed for pembrolizumab.

No statistical analyses for this end point

Secondary: Part 2 - Tmax for pembrolizumab after first dose

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End point title

Part 2 - Tmax for pembrolizumab after first dose ^[118]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[118] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[119]
Units: Hour
geometric mean (geometric coefficient of variation)	±

Notes
[119] - PK data were not collected and analyzed for pembrolizumab.

No statistical analyses for this end point

Secondary: Part 1 - AUC (0-tau) for pembrolizumab after first dose

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End point title

Part 1 - AUC (0-tau) for pembrolizumab after first dose ^[120]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[120] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[121]	0 ^[122]
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	±	±

Notes
[121] - PK data were not collected and analyzed for pembrolizumab.
[122] - PK data were not collected and analyzed for pembrolizumab.

No statistical analyses for this end point

Secondary: Part 2 - AUC (0-tau) for pembrolizumab after first dose

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End point title

Part 2 - AUC (0-tau) for pembrolizumab after first dose ^[123]

End point description

End point type

Secondary

End point timeframe

Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1

Notes
[123] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[124]
Units: h*ug/mL
geometric mean (geometric coefficient of variation)	±

Notes
[124] - PK data were not collected and analyzed for pembrolizumab.

No statistical analyses for this end point

Secondary: Part 1 - Number of participants with post-baseline positive anti-drug antibodies (ADAs) against belantamab mafodotin

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End point title

Part 1 - Number of participants with post-baseline positive anti-drug antibodies (ADAs) against belantamab mafodotin ^[125]

End point description

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.

End point type

Secondary

End point timeframe

Baseline (Day 1) and up to approximately 31 months

Notes
[125] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	6	7
Units: Participants	0	0

No statistical analyses for this end point

Secondary: Part 2 - Number of participants with post-baseline positive ADAs against belantamab mafodotin

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End point title

Part 2 - Number of participants with post-baseline positive ADAs against belantamab mafodotin ^[126]

End point description

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[126] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	26
Units: Participants	0

No statistical analyses for this end point

Secondary: Part 1 - Titers of ADAs against belantamab mafodotin

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End point title

Part 1 - Titers of ADAs against belantamab mafodotin ^[127]

End point description

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.

End point type

Secondary

End point timeframe

Up to approximately 31 months

Notes
[127] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[128]	0 ^[129]
Units: Titers
median (full range (min-max))	( to )	( to )

Notes
[128] - As there were no positive ADA results, there were no titer values..
[129] - As there were no positive ADA results, there were no titer values..

No statistical analyses for this end point

Secondary: Part 2 - Titers of ADAs against belantamab mafodotin

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End point title

Part 2 - Titers of ADAs against belantamab mafodotin ^[130]

End point description

End point type

Secondary

End point timeframe

Baseline and up to approximately 31 months

Notes
[130] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoints are different for the different parts of the study. Hence, for any given endpoint, results are presented either for Part 1 or Part 2 arm.

End point values	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Number of subjects analysed	0 ^[131]
Units: Titers
median (full range (min-max))	( to )

Notes
[131] - No participants with positive ADA results, hence titer (concentration) was not collected.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 31 months.

Adverse event reporting additional description

Data analysis is still on-going & additional results will be provided after study completion.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Reporting group description

Reporting group title

Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg

Reporting group description

Reporting group title

Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg

Reporting group description

Belantamab mafodotin RP2D of 2.5 mg/kg in combination with fixed dose of 200 mg of pembrolizumab determined in the Dose Escalation phase was administered to participants via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

Serious adverse events	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 6 (66.67%)	5 / 7 (71.43%)	5 / 28 (17.86%)
number of deaths (all causes)	2	3	5
number of deaths resulting from adverse events	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Plasmacytoma
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cytokine release syndrome
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Hypoxia
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Mental status changes
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Platelet count decreased
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infusion related reaction
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	2 / 28 (7.14%)
occurrences causally related to treatment / all	1 / 1	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial flutter
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Large intestinal haemorrhage
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Bacteraemia
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	2 / 28 (7.14%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leishmaniasis
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 6 (16.67%)	1 / 7 (14.29%)	4 / 28 (14.29%)
occurrences causally related to treatment / all	0 / 1	1 / 2	2 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia haemophilus
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	2 / 6 (33.33%)	0 / 7 (0.00%)	0 / 28 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypoglycaemia
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 28 (3.57%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Part 1: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg	Part 1: Belantamab mafodotin 3.4 mg/kg + Pembrolizumab 200 mg	Part 2: Belantamab mafodotin 2.5 mg/kg + Pembrolizumab 200 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	6 / 6 (100.00%)	6 / 7 (85.71%)	27 / 28 (96.43%)
Vascular disorders
Hypertension
subjects affected / exposed	1 / 6 (16.67%)	2 / 7 (28.57%)	2 / 28 (7.14%)
occurrences all number	1	2	2
General disorders and administration site conditions
Fatigue
subjects affected / exposed	3 / 6 (50.00%)	3 / 7 (42.86%)	3 / 28 (10.71%)
occurrences all number	9	5	3
Pyrexia
subjects affected / exposed	1 / 6 (16.67%)	4 / 7 (57.14%)	10 / 28 (35.71%)
occurrences all number	1	4	12
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	3 / 6 (50.00%)	2 / 7 (28.57%)	2 / 28 (7.14%)
occurrences all number	3	2	3
Epistaxis
subjects affected / exposed	2 / 6 (33.33%)	0 / 7 (0.00%)	2 / 28 (7.14%)
occurrences all number	3	0	3
Pleural effusion
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	2 / 28 (7.14%)
occurrences all number	1	0	2
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	2 / 28 (7.14%)
occurrences all number	0	1	2
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	3 / 28 (10.71%)
occurrences all number	1	0	3
Aspartate aminotransferase increased
subjects affected / exposed	2 / 6 (33.33%)	0 / 7 (0.00%)	4 / 28 (14.29%)
occurrences all number	2	0	4
Platelet count decreased
subjects affected / exposed	0 / 6 (0.00%)	0 / 7 (0.00%)	3 / 28 (10.71%)
occurrences all number	0	0	3
Visual acuity tests abnormal
subjects affected / exposed	1 / 6 (16.67%)	1 / 7 (14.29%)	1 / 28 (3.57%)
occurrences all number	2	2	5
Weight decreased
subjects affected / exposed	0 / 6 (0.00%)	2 / 7 (28.57%)	1 / 28 (3.57%)
occurrences all number	0	2	1
Injury, poisoning and procedural complications
Infusion related reaction
subjects affected / exposed	2 / 6 (33.33%)	1 / 7 (14.29%)	7 / 28 (25.00%)
occurrences all number	2	1	7
Nervous system disorders
Headache
subjects affected / exposed	2 / 6 (33.33%)	2 / 7 (28.57%)	1 / 28 (3.57%)
occurrences all number	3	2	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	4 / 6 (66.67%)	3 / 7 (42.86%)	5 / 28 (17.86%)
occurrences all number	5	3	5
Neutropenia
subjects affected / exposed	2 / 6 (33.33%)	2 / 7 (28.57%)	2 / 28 (7.14%)
occurrences all number	3	4	5
Thrombocytopenia
subjects affected / exposed	3 / 6 (50.00%)	3 / 7 (42.86%)	9 / 28 (32.14%)
occurrences all number	4	6	10
Eye disorders
Blepharitis
subjects affected / exposed	3 / 6 (50.00%)	0 / 7 (0.00%)	0 / 28 (0.00%)
occurrences all number	7	0	0
Dry eye
subjects affected / exposed	3 / 6 (50.00%)	1 / 7 (14.29%)	4 / 28 (14.29%)
occurrences all number	4	2	4
Eye pruritus
subjects affected / exposed	2 / 6 (33.33%)	1 / 7 (14.29%)	0 / 28 (0.00%)
occurrences all number	2	1	0
Keratopathy
subjects affected / exposed	6 / 6 (100.00%)	6 / 7 (85.71%)	20 / 28 (71.43%)
occurrences all number	7	7	24
Photophobia
subjects affected / exposed	2 / 6 (33.33%)	1 / 7 (14.29%)	3 / 28 (10.71%)
occurrences all number	2	1	3
Vision blurred
subjects affected / exposed	3 / 6 (50.00%)	2 / 7 (28.57%)	10 / 28 (35.71%)
occurrences all number	4	2	10
Gastrointestinal disorders
Constipation
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	2 / 28 (7.14%)
occurrences all number	0	2	2
Diarrhoea
subjects affected / exposed	1 / 6 (16.67%)	1 / 7 (14.29%)	2 / 28 (7.14%)
occurrences all number	1	1	2
Nausea
subjects affected / exposed	3 / 6 (50.00%)	1 / 7 (14.29%)	7 / 28 (25.00%)
occurrences all number	3	2	7
Vomiting
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	3 / 28 (10.71%)
occurrences all number	0	1	3
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	2 / 28 (7.14%)
occurrences all number	1	0	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	2 / 28 (7.14%)
occurrences all number	0	1	2
Musculoskeletal chest pain
subjects affected / exposed	0 / 6 (0.00%)	1 / 7 (14.29%)	2 / 28 (7.14%)
occurrences all number	0	1	2
Pain in extremity
subjects affected / exposed	1 / 6 (16.67%)	0 / 7 (0.00%)	2 / 28 (7.14%)
occurrences all number	2	0	4
Infections and infestations
Urinary tract infection
subjects affected / exposed	1 / 6 (16.67%)	2 / 7 (28.57%)	0 / 28 (0.00%)
occurrences all number	3	2	0
Metabolism and nutrition disorders
Hypokalaemia
subjects affected / exposed	1 / 6 (16.67%)	1 / 7 (14.29%)	2 / 28 (7.14%)
occurrences all number	1	1	2
Hypomagnesaemia
subjects affected / exposed	0 / 6 (0.00%)	2 / 7 (28.57%)	1 / 28 (3.57%)
occurrences all number	0	2	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

26 Sep 2018

The statistical model in dose escalation was revised from Bayesian Logistic Regression Model to mTPI and the overall sample size and related analytical methods had been changed. Part 2 stopping criteria had been added for continuous safety monitoring

26 Feb 2020

The protocol had been amended to address feedback from regulatory agencies, inclusions of items noted in protocol clarification letters, revisions due to discrepancies, revision of study drug related language, and other clarifications. DLT evaluable population was included to analysis population to further define Part 1 population.

27 Aug 2021

The protocol had been amended to update pembrolizumab safety, ECI overdose language, and standard text based on latest IB update for pembrolizumab (2021) and belantamab mafodotin (2021). Added the primary analysis at approximately 15 months follow-up from LSLV. Updated the planned derived PK parameters and PK/PD analyses, updated the data monitoring language, medical monitoring information, and SAE reporting.

21 Feb 2022

The protocol had been amended to provide updates including the addition of the end of study definition section and continued access to study intervention after the end of the study section (Post Analysis Continued Treatment [PACT]).

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma (DREAMM 4)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Part 1 - Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Primary: Part 1 - Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Primary: Part 1 - Number of participants with dose limiting toxicities (DLTs)

Primary: Part 1 - Number of participants with dose limiting toxicities (DLTs)

Primary: Part 1 - Number of participants with worst-case grade change from baseline in hematology parameters

Primary: Part 1 - Number of participants with worst-case grade change from baseline in hematology parameters

Primary: Part 1 - Number of participants with worst-case change post-baseline in hematology parameters

Primary: Part 1 - Number of participants with worst-case change post-baseline in hematology parameters

Primary: Part 1 - Number of participants with worst-case grade change from baseline in lab chemistry parameters

Primary: Part 1 - Number of participants with worst-case grade change from baseline in lab chemistry parameters

Primary: Part 1 - Number of participants with worst-case change post-baseline in lab chemistry parameters

Primary: Part 1 - Number of participants with worst-case change post-baseline in lab chemistry parameters

Primary: Part 1 - Number of participants with abnormal urinalysis results

Primary: Part 1 - Number of participants with abnormal urinalysis results

Primary: Part 1 - Changes from baseline in urine potential of hydrogen (pH) at indicated time points

Primary: Part 1 - Changes from baseline in urine potential of hydrogen (pH) at indicated time points

Primary: Part 1 - Changes from baseline in urine specific gravity at indicated time points

Primary: Part 1 - Changes from baseline in urine specific gravity at indicated time points

Primary: Part 1 - Number of participants with worst-case grade change from baseline in vital signs: diastolic blood pressure (DBP) and systolic blood pressure (SBP)

Primary: Part 1 - Number of participants with worst-case grade change from baseline in vital signs: diastolic blood pressure (DBP) and systolic blood pressure (SBP)

Primary: Part 1 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature

Primary: Part 1 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature

Primary: Part 2 - Percentage of participants with overall response rate (ORR)

Primary: Part 2 - Percentage of participants with overall response rate (ORR)

Secondary: Part 1 - Percentage of participants with ORR

Secondary: Part 1 - Percentage of participants with ORR

Secondary: Part 2 - Number of participants with AEs and SAEs

Secondary: Part 2 - Number of participants with AEs and SAEs

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in hematology parameters

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in hematology parameters

Secondary: Part 2 - Number of participants with worst-case change post-baseline in hematology parameters

Secondary: Part 2 - Number of participants with worst-case change post-baseline in hematology parameters

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in lab chemistry parameters

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in lab chemistry parameters

Secondary: Part 2 - Number of participants with worst-case change post-baseline in lab chemistry parameters

Secondary: Part 2 - Number of participants with worst-case change post-baseline in lab chemistry parameters

Secondary: Part 2 - Number of participants with abnormal urinalysis results

Secondary: Part 2 - Number of participants with abnormal urinalysis results

Secondary: Part 2 - Changes from baseline in urine specific gravity at indicated time points

Secondary: Part 2 - Changes from baseline in urine specific gravity at indicated time points

Secondary: Part 2 - Changes from baseline in urine pH at indicated time points

Secondary: Part 2 - Changes from baseline in urine pH at indicated time points

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in vital signs: DBP and SBP

Secondary: Part 2 - Number of participants with worst-case grade change from baseline in vital signs: DBP and SBP

Secondary: Part 2 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature

Secondary: Part 2 - Number of participants with worst-case change from baseline in vital signs: pulse rate and body temperature

Secondary: Part 2 - Number of participants with maximum worst-case change from baseline in best corrected visual acuity test (BCVA) scores

Secondary: Part 2 - Number of participants with maximum worst-case change from baseline in best corrected visual acuity test (BCVA) scores

Secondary: Part 2 - Time taken for the onset of first occurrence of worsening in BCVA score

Secondary: Part 2 - Time taken for the onset of first occurrence of worsening in BCVA score

Secondary: Part 2 - Outcome of first occurrence of worsening eye in BCVA score

Secondary: Part 2 - Outcome of first occurrence of worsening eye in BCVA score

Secondary: Part 2 - Duration of first occurrence of worsening in BCVA score

Secondary: Part 2 - Duration of first occurrence of worsening in BCVA score

Secondary: Part 2 - Number of events of participants with definite worsen vision of worsening in BCVA score

Secondary: Part 2 - Number of events of participants with definite worsen vision of worsening in BCVA score

Secondary: Part 2 - Number of participants with outcome post treatment exposure of worsening in BCVA score

Secondary: Part 2 - Number of participants with outcome post treatment exposure of worsening in BCVA score

Secondary: Part 2 - Duration of resolution post-treatment exposure of worsening in BCVA score

Secondary: Part 2 - Duration of resolution post-treatment exposure of worsening in BCVA score

Secondary: Part 2 - Number of participants with post-baseline decline in BCVA to light perception or no light perception

Secondary: Part 2 - Number of participants with post-baseline decline in BCVA to light perception or no light perception

Secondary: Part 2 - Number of participants with worst-case shift from baseline in ophthalmological epithelium exam

Secondary: Part 2 - Number of participants with worst-case shift from baseline in ophthalmological epithelium exam

Secondary: Part 2 - Number of participants with worst-case shift from baseline in corneal examinations

Secondary: Part 2 - Number of participants with worst-case shift from baseline in corneal examinations

Secondary: Part 2 - Number of participants with worse case post-baseline punctate keratopathy findings

Secondary: Part 2 - Number of participants with worse case post-baseline punctate keratopathy findings

Secondary: Part 2 - Number of participants with worst-case shift from baseline in lens examinations

Secondary: Part 2 - Number of participants with worst-case shift from baseline in lens examinations

Clinical Trial Results:
A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma (DREAMM 4)